FDA.reportPublic FDA data

Sucralfate

Product NDC
65162-062
11-digit product format
651620062
Labeler code
65162
Product ID
65162-062_71ed86a3-ff8a-4545-9bae-26632466fd80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate Oral
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA209356
Marketing category
ANDA
Marketing start
2019-12-02
Substance
SUCRALFATE
Active strength
1 g/10mL
Pharmacologic classes
Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXX73205DH5
Rxcui313123

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-062-05Sucralfate420 mL in 1 BOTTLESUSPENSION42018
65162-062-47Sucralfate10 mL in 1 CUP, UNIT-DOSESUSPENSION1018
65162-062-48Sucralfate10 in 1 TRAYSUSPENSION1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-062-05ML - Milliliter65162-062ff5e5cbb-cdbc-4017-bc65-9814869f19cd12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-062SUCRALFATE (SUCRALFATE ORAL) SUSPENSION [AMNEAL PHARMACEUTICALS LLC]18Current NDC, Legacy NDC, 3 package rows20241031_4350b771-76a9-4e00-93f0-a18c71288f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN4350b771-76a9-4e00-93f0-a18c71288f8318
313123sucralfate 100 MG/ML Oral SuspensionSCD4350b771-76a9-4e00-93f0-a18c71288f8318
313123sucralfate 1 GM per 10 ML Oral SuspensionSY4350b771-76a9-4e00-93f0-a18c71288f8318
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN0dc592e9-541c-4fac-8ab5-829d43521c012
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN573f74bc-6a49-4412-9eee-4275360798512
313123sucralfate 100 MG/ML Oral SuspensionSCD0dc592e9-541c-4fac-8ab5-829d43521c012
313123sucralfate 100 MG/ML Oral SuspensionSCD573f74bc-6a49-4412-9eee-4275360798512
313123sucralfate 1 GM per 10 ML Oral SuspensionSY0dc592e9-541c-4fac-8ab5-829d43521c012
313123sucralfate 1 GM per 10 ML Oral SuspensionSY573f74bc-6a49-4412-9eee-4275360798512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-062-0565162006205420 mL in 1 BOTTLE (65162-062-05) 420 ml2019-12-020000-00-00NoNoCurrent
65162-062-476516200624710 mL in 1 CUP, UNIT-DOSE10 mlHistorical
65162-062-486516200624810 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47) 2019-12-020000-00-00NoNoCurrent